FDAClass IIAugust 2, 2023

Safe Tussin DM Cough + Chest Congestion recall: CGMP Deviations

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Why was Safe Tussin DM Cough + Chest Congestion recalled?

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 8753, 8753A, Exp. Date 10/2023 Lot #: 8659 Exp. Date 8/2023

Product
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
Recalling firm
Kramer Laboratories, Inc.
Quantity
N/A
Distribution
nationwide within the United States
Recall date
August 2, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls